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It's every drug- and devicemaker’s worst nightmare — inspectors coming through your front door with the power to shut you down. They're highly trained … ruthlessly committed to spotting your tiniest flaws … and tough as nails. If only you could question investigators in detail … before an inspection. Maybe you'd learn what you need to do to pass. Would they tell you? The answer is yes.
Riverside, Calif.-based Pacific Consolidated Industries received a nine-count Form 483 after inspectors from the Irvine, Calif., CDRH office found deviations in the company’s complaint and adverse event handling activities. The report followed a Jan. 31 – Feb. 13 inspection of the portable and mobile air separation equipment maker. The inspectors found several cases where five-day MDR reports were not submitted to the FDA in a timely manner. The GMP Letter